On certification to the Superior Court, Appellate Division.
For reversal and remandment -- Chief Justice Wilentz and Justices Clifford, Handler, Pollock, O'Hern, Garibaldi and Stein. For affirmance -- None. The opinion of the Court was delivered by O'Hern, J.
Gregory Niemiera, II is a seven-year-old child who suffered at age two months a disabling convulsive episode that left him brain damaged. Through his parents he alleges that the injuries resulted from an adverse reaction to a childhood vaccine. The central issue in his appeal is whether the "learned-intermediary" doctrine relieves the manufacturer of a childhood vaccine of the duty to warn patients directly of the vaccine's dangerous side effects. The vaccine here is DPT. Its tri-fold components protect against diphtheria, pertussis (whooping cough), and tetanus. The adverse reaction here is laid to the pertussis component of the vaccine.
The plaintiffs assert that the almost universal administration of the vaccine to infants equates with mass inoculation, an instance in which the pharmaceutical manufacturer should be held to owe an independent duty to warn patients of the danger of such adverse reactions. We disagree. The role of the physician with respect to DPT requires an exercise in medical judgment concerning when and under what circumstances the vaccine shall be administered. Hence we affirm the judgment below holding that the pharmaceutical manufacturer, Wyeth Laboratories, had no independent duty to warn of DPT's potentially catastrophic side effects.
To the extent that the pharmaceutical manufacturer is relieved of the duty to warn, the treating physician as the learned intermediary assumes a responsibility to warn the patient of the risks involved in taking the vaccine. We find that in this case, although the jury resolved all issues in the defendant-physician's favor concerning other aspects of professional treatment, the jury was not permitted to consider whether the patient was adequately informed of the risks of the vaccine. We are of course uncertain whether on that question the jury would have found in the defendant's favor as well, i.e., finding the warnings either adequate or, if inadequate, not a proximate cause of the infant's condition, but we are regrettably unable to
make that decision on the basis of this record. Hence that issue must be submitted to the jury.
As noted, the minor's condition is one of severe brain damage resulting from acute encephalopathy (a term identifying an illness with symptoms indicating an inflammation of the brain, but that on examination does not reveal any such inflammation) diagnosed within eight days of the inoculation with DPT. Gregory suffered convulsive seizures, which ravaged his central nervous system, and he will have impaired vision, be cerebrally palsied, and be mentally defective for the rest of his life. Plaintiff sued both Wyeth Laboratories, the manufacturer of DPT, and his physicians. (We shall refer to both Gregory and his parents as "plaintiff.")
Plaintiff contended that Wyeth Laboratories owed him an independent duty to warn that DPT had potentially devastating side effects -- among them, brain damage and death.*fn1 Plaintiff's mother, although she was a nurse, testified, as did her husband, that she knew of no such possible side effects of what she thought was a routine "well-baby" inoculation against childhood diseases. Before trial, Wyeth Laboratories succeeded in its pretrial motion to dismiss plaintiff's complaint for failure to warn on the basis of the "learned intermediary" doctrine. We shall discuss that aspect of the judgment in Part III of this opinion.
At trial, plaintiff presented four bases of professional responsibility to be assessed against the physician: (1) failure to warn of the vaccine's side effects; (2) failure to heed the contraindications in the child's condition prior to administering the vaccine; (3) failure to treat when the early adverse symptoms were disclosed; and (4) failure to treat properly when the symptoms escalated.
The trial thus focused on many complex issues that are not before us for resolution. Even if the doctor were negligent, the jury had to consider the more fundamental underlying question of whether DPT was the cause of his resulting condition. There was surely enough evidence in the case for the jury to have found that an independent condition such as a urinary tract infection might have caused the convulsions and disorders that left Gregory permanently brain damaged. The jury did answer a special interrogatory finding that the physician had not been negligent.
The claim arises from a routine "well-baby" visit of Gregory Niemiera to his pediatrician on April 5, 1982. Gregory was then approximately ten weeks old. He was a nursing baby and thus ordinarily more immune to infectious diseases. On an earlier visit, February 17, 1982, he had presented a slight eye discharge. Plaintiff claims that on the April 5 visit Gregory still had the discharge from his eyes. Dr. Schneider, his pediatrician, examined the baby on April 5 and considered his medical history. In his opinion, it was safe to administer the DPT vaccine. Dr. Schneider testified that his usual routine was quickly to review personally "the fact that the baby was of the age to be given the immunization, [and] to review the usual side effects and precautions" before sending the child for a shot. Normally he would also advise the mother of typical post-shot reactions including irritability, redness and swelling at the area of the injection, and possibly a fever. Finally, he would tell the
mother that the baby could be given Tylenol to treat any fever or irritability. He could not recall whether he followed that procedure in this case. It was not disputed that subsequent to the inoculation, Mrs. Niemiera received from the administering nurse a printed paper describing these as possible post-shot reactions to the treatment. As was the doctor's custom, he left the actual administration to a nurse.
According to Mrs. Niemiera, on April 7, 1982, she called Dr. Schneider's office because Gregory was not nursing and was still running a low-grade fever. Although mild fever is a typical post-shot reaction, she was disturbed that he was still running a fever two days after the inoculation. Dr. Schneider was not in, but later that day Dr. Formalont, a partner of Dr. Schneider's, returned the call. By Mrs. Niemiera's account, Dr. Formalont advised her that she should not be concerned because Gregory was probably just suffering from a flu. The entire incident was disputed by Dr. Schneider who claimed that according to his office records Dr. Formalont was not working that day and therefore would not have returned the call.
Mrs. Niemiera also testified that she called Dr. Schneider's office again on April 9, 1982, because the baby's condition had worsened. Gregory was now vomiting, crying uncontrollably, and still did not want to eat. Dr. Schneider prescribed pedialyte, a medication to replace body fluids, and told Mrs. Niemiera to call again if Gregory had blood or mucus in his stool. This phone call was received by Dr. Schneider and noted in his office chart. Neither Dr. Schneider, Dr. Formalont, nor any other member of the Princeton-Nassau Pediatric Group examined Gregory on April 7 or April 9. According to plaintiffs, on Saturday, April 10, Gregory's condition was "a little bit better," and by Sunday morning, April 11, he was "pretty good." That day was Easter Sunday. Gregory was taken to church and to family dinner. It was Gregory's last day of normal childhood.
On the morning of Monday, April 12, 1988, Mr. and Mrs. Niemiera awoke to find Gregory lying on his stomach. His crib
was full of his waste. He was unresponsive, running a high fever, and suffering periodic seizures. At one point he stopped breathing. The Niemieras rushed Gregory to the Princeton Medical Center where he was seen by Dr. Schneider. Later he was transferred by ambulance to Children's Hospital of Philadelphia (CHOP) where he received "intensive and extensive" treatment. While at CHOP Gregory was diagnosed as having acute encephalopathy resulting in severe and permanent brain damage.
The exact cause of the convulsive illness was disputed. Early infusion of antibiotics, to prevent bacterial disorder, and the loss of early blood specimens make difficult an expert determination of cause. There was an infection in Gregory's bladder, but plaintiff's expert said that might have been a result, not a cause, of the child's bowel movements. At one time Dr. Schneider, the pediatrician, had rendered an opinion that the episode was caused by the vaccination.
Plaintiff's expert witness believed that Gregory's brain damage was caused by an adverse reaction to the DPT vaccine. He testified that it is normal for a child to receive the DPT vaccine several times in his early years, and that the symptoms of an adverse reaction to the initial inoculation may be different from an adverse reaction to subsequent inoculations. He claimed that the progress of the symptoms in this case, particularly the intermittent fever, were not inconsistent with a pertussis reaction to an initial DPT vaccination. He admitted, however, that ordinarily any severe adverse reaction, such as convulsions, occurs within seventy-two hours. Dr. Schneider and his expert contended that Gregory's symptoms were unrelated to the DPT shot, but were in fact caused by some independent medical illness, possibly the urinary tract infection.
Gregory's expert testified that good medical practice requires that a patient be informed of the symptoms that would indicate a potentially-catastrophic adverse reaction to the Pertussis vaccine. In his view, "it needed to be spelled out more clearly,
then one would have to say, this could cause a real problem in the brain and nervous system, and these are things you must watch." The "things you must watch" include severe and inconsolable crying, intermittent high fever, and loss of appetite. It should also include the fact that, at least with the initial DPT vaccination, symptoms of a bad reaction may disappear and reappear over several days, and that the presence of these symptoms should be immediately reported to a doctor. (The information sheet that Mrs. Niemiera received instructed her only to report any symptoms at the next visit to the doctor.) The onset of the disease is not ...